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Completed

NCT Number: NCT01242644

Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.

Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All subjects who underwent:

  • knee arthroscopy + synovectomy
  • knee arthroscopy + partial or complete meniscectomy
  • knee arthroscopy + chondroplasty
  • knee arthroscopy + microfracture
  • knee arthroscopy + autologous osteoarticular transplantation

Exclusion criteria

  • A surgical procedure that required an incision other then an arthroscopic portal
  • A surgical procedure within the same joint within ninety days
  • A acute or chronic knee infection
  • Any diagnosis of complex regional pain syndrome
  • A known allergy to one of the study drugs
  • A documented history of narcotic use
  • A score of less than two standard deviation on the SF-12 mental component
  • Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
  • Under the age of eighteen years

Treatment and study plan

pain pump containing ropivacaine

Device

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour

Other names: ropivacaine, pain, pump

saline pain pump with injectable medication

Device

30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour

Other names: ketorolac, saline

ropivacaine, ketorolac , morphine sulfate

Drug

30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected

Other names: morphine, sulfate

Primary outcomes

  1. Pain Score 8 Hours Post-operativley

    Time frame: 8 hours post surgery

    Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  2. Pain Scale

    Time frame: 24 hours post surgery

    Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  3. Pain Scale

    Time frame: 48 hours post-surgery

    Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  4. Pain Scale

    Time frame: 72 hours post surgery

    Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

Secondary outcomes

  1. Number of Narcotic Pills and Morphine Sulfate Used

    Time frame: In recovery room

    Pill count

  2. Number of Narcotic Pills and Morphine Sulfate Used

    Time frame: Post surgery day 1

    Pill Count

  3. Number of Narcotic Pills and Morphine Sulfate Used

    Time frame: Post surgery day 2

  4. Number of Narcotic Pills and Morphine Sulfate Used

    Time frame: Post surgery day 3

Sponsors and collaborators

Lead sponsor

University of South Alabama

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Nov 17, 2010
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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